Actively Recruiting
Angiotensin-Neprilysin Inhibition in Hemodialysis Initiation
Led by Brigham and Women's Hospital · Updated on 2025-11-26
100
Participants Needed
1
Research Sites
198 weeks
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This randomized placebo-controlled clinical trial will evaluate the effect of sacubitril/valsartan (compared with placebo) on echocardiographic measures of hypervolemia, preservation of residual renal function, and key safety parameters in incident hemodialysis patients.
CONDITIONS
Official Title
Angiotensin-Neprilysin Inhibition in Hemodialysis Initiation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older starting hemodialysis within 90 days of first session
- Receiving hemodialysis three times a week
- Able to provide informed consent
- Hemodynamically stable with sitting pre-dialysis systolic blood pressure at least 110 mmHg averaged over the past two weeks
- No symptomatic low blood pressure in the past two weeks
- Not using midodrine medication
- Has not taken an ACE inhibitor for 36 hours before randomization
You will not qualify if you...
- Urine output less than 100 mL per day (anuria)
- Use of sacubitril/valsartan within the past 30 days
- History of allergy or intolerance to study drugs including ARBs or sacubitril/valsartan
- Angioedema from previous ACE inhibitor, ARB, or ARNI treatment
- High serum potassium greater than 5.5 mEq/L at screening
- Recent serious heart or brain events within one month (acute coronary syndrome, stroke, TIA, major surgery, or angioplasty)
- Planned heart or blood vessel procedures within 3 to 4 months
- Recent or planned implantation of certain heart devices
- History or planned heart transplant or use of ventricular assist device
- Planned kidney transplant within 4 months
- Untreated ventricular arrhythmia with fainting episodes within 3 months
- Symptomatic slow heart rate or advanced heart block without pacemaker
- Significant heart valve disease or specific heart muscle diseases including amyloidosis
- Cancer within the past year except certain skin and cervical cancers considered cured
- Liver disease or abnormal liver test results unless Gilbert's disease
- Pregnant or breastfeeding women
- Participation in another interventional trial
- Recent use of other investigational drugs or devices within 12 weeks
- Inability to consent due to cognitive impairment
- Any condition making participation unsafe or inappropriate
- Women of childbearing potential not using two effective birth control methods during and shortly after treatment
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Trial Site Locations
Total: 1 location
1
Brigham and Women's
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
F
Finnian R Mc Causland, MBCCh, MMSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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